Rigorous adherence to the principles of asepsis is the foundation of surgical site infection prevention. It is critical to minimize exposure of the wound to bacterial contamination from bacteria on the patient's skin, members of the surgical team, and from non-sterile equipment in the operating room through the use of gloves, gowns, masks, and drapes. Draping of the surgical site provides a sterile work surface and helps minimize the transfer of microorganisms between non-sterile areas and the surgical wound. These measures also may help protect health care professionals from exposure to pathogens in the patient's blood and other body fluids. To help prevent surgical site infection, it is critical to reduce and restrict microorganisms from entering the open surgical wound. Incise drapes, such as Steri-Drape™ drape and Ioban™ 2 Antimicrobial Skin Prepping System from 3M, provide a sterile surface to the wound edge during surgery. The film adheres securely to wound edges, which is critical in maintaining the barrier to skin flora. Some incise drapes such as Ioban™ 2 contain an antimicrobial agent, preferably iodophor, in the adhesive so that the drape itself provides antimicrobial activity.
A pressure sensitive adhesive having a broad spectrum antimicrobial contained therein is disclosed in U.S. Pat. No. 4,310,509. When the adhesive composition is placed in contact with the skin, it uniformly and controllably releases the broad spectrum antimicrobial agent. The process as described therein involves forming an emulsifiable concentrate or an organic solution concentrate of the broad spectrum antimicrobial and mixing it into the adhesive such that the broad spectrum antimicrobial is homogeneously dispersed as a separate phase throughout the adhesive medium. U.S. Pat. No. 4,323,557 discloses pressure sensitive adhesives that are stable complexes of iodine, an iodide ion and a dermatologically acceptable normally room temperature tacky pressure sensitive adhesive.
Solventless hot melt adhesive compositions containing a specific antimicrobial agent, diiodomethyl-p-tolylsulfone, are described in U.S. Pat. Nos. 6,216,699 and 5,829,422. This compound is stated to be a heat stable antimicrobial agent at column five, lines 47–56 (in the '699 patent). The addition of this heat stable antimicrobial agent to the adhesive composition is stated to provide an effective antimicrobial adhesive which retains desirable properties during use and application even after the adhesive has been processed at temperatures in the range of 275° F. to 350° F.
PCT publications W0 00/56828 and W0 00/78885 describe wet stick pressure sensitive adhesives comprising the polymerization product of defined monomers, wherein the pressure sensitive adhesive adheres to wet surface substrates. These adhesives may be made by a hot melt coating process, and additionally may be used in conjunction with surgical drapes. These references do not disclose the incorporation of antimicrobial agents in the adhesive.
U.S. Pat. No. 5,369,155 discloses a composite of gel of swollen hydrocolloid dispersed in a pressure sensitive adhesive matrix. The gel-adhesive composite may be used with surgical incise drapes, and may optionally incorporate antimicrobial agents. A list of optional antimicrobial agents is provided at column 12, lines 32–39, which includes iodine and iodophors. In the examples, the composite is coated from a solvent onto a release liner and laminated to a backing.
Active substance plasters are described in U.S. Pat. No. 6,143,317. These plasters comprise a backing material having a foamed hot melt adhesive composition comprising an active substance. The list of active substances that may be incorporated in the foamed hot melt adhesive includes iodine, but there is no disclosure of how such an iodine would be incorporated, and no disclosure of the complexing agent for iodine and iodide ion compositions.